MAUDE Adverse Event Report: ALCON - COUVREUR N.V./ALCON - BELGIUM VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

Catalog Number ASKU

Device Problem Particulates (1451)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2015

Event Type  malfunction  

Manufacturer Narrative

No sample or lot number information has been received by manufacturing for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Additional information has been requested, but no additional information is anticipated.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that particulates were detected inside of the viscoelastic solution.Procedure details and patient impact information is unknown.Additional information has been requested.Additional information was received which confirmed that the particulates were noted during multiple procedures.The particulates were removed during each respective procedure with no further information available.

Manufacturer Narrative

All batches are released according to the required specifications and all testing results were within specification for this batch.A small amount of silicone was found in the initial samples.Our lab has retested a reference sample of this batch and all results conformed to the specifications for the tested parameters.To date, no customer sample was returned for evaluation so no further investigation towards the actual origin of the reported particulates can be performed.We can however inform you that a 100% visual inspection process of all filled syringes is performed to remove syringes with large silicone droplets.The silicone oil used is manufactured and tested in compliance with good manufacturing practices at an iso certified facility.Medical grade silicone is used to coat all types of stoppers and syringe barrels to permit proper function of the syringe.The low levels of silicone oil do not elicit local ocular or systemic toxicity.The root cause of this reported event is inconclusive as the reserve sample product met specifications.(b)(4).

Event Description

Additional information was received on a returned questionnaire confirming that there was no patient impact.

• Brand Name: VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): ALCON - COUVREUR N.V./ALCON - BELGIUM; rijksweg 14; puurs B-287 0; BE B-2870
• Manufacturer (Section G): ALCON - COUVREUR N.V./ALCON - BELGIUM; rijksweg 14; puurs B-287 0; BE B-2870
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5242817
• MDR Text Key: 32137385
• Report Number: 3002037047-2015-00574
• Device Sequence Number: 1
• Product Code: LZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: ASKU
• Device Lot Number: 15F03V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other